Study on Trastuzumab and Pertuzumab or Cetuximab and Irinotecan for Treating Advanced HER2/Neu Amplified Colorectal Cancer

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03365882

Provider View

This clinical trial is comparing two treatment combinations to see which works better for patients with advanced colorectal cancer that cannot be removed by surgery. The study focuses on cancers with a specific genetic change called HER2/neu amplification.

Patient Parameters

Program Overview

This study is testing two different treatment combinations for patients with advanced colorectal cancer that has a specific genetic change called HER2/neu amplification. The cancer has spread and cannot be removed by surgery. The trial compares the effectiveness of trastuzumab and pertuzumab, which are monoclonal antibodies, against cetuximab and irinotecan, which are chemotherapy drugs. The goal is to see which combination is more effective in stopping the cancer from growing and spreading.

Description

The main goal of this study is to see if the combination of trastuzumab and pertuzumab (TP) is more effective than cetuximab and irinotecan (CETIRI) in treating advanced colorectal cancer with HER2 amplification. Researchers will compare how long patients live without the cancer getting worse (progression-free survival) between the two groups.

Secondary goals include comparing the overall response rate, which measures how much the cancer shrinks, and overall survival between the two treatment groups. The study will also look at the safety and side effects of the treatments.

Patients with HER2 gene amplification will be randomly assigned to one of two groups:

  • Group 1: Receives trastuzumab and pertuzumab intravenously every 21 days.
  • Group 2: Receives cetuximab and irinotecan intravenously every 14 days.

If the cancer progresses on the CETIRI treatment, patients may switch to the TP treatment.

After finishing the study treatment, patients will be monitored for three years to track their health and any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Have advanced colorectal cancer that cannot be removed by surgery and has spread.
  • Have a specific genetic change called HER2 amplification.
  • Have had at least one previous chemotherapy treatment for advanced cancer.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood counts and organ function as determined by specific medical tests.
  • Not have severe allergies to the study drugs.
  • Not be pregnant or nursing and agree to use effective contraception during the study and for seven months after.
  • Be willing to provide a tumor sample for HER2 testing and sign informed consent to participate in the study.

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